NL-OMON39343
Not yet recruiting
Phase 4
Magnetic Resonance Imaging to diagnose endometriosis using Ablavar ® as contrast agent - a feasibility study - Ablavar ® in endometriosis diagnosis
Medisch Universitair Ziekenhuis Maastricht0 sites5 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- endometriosis
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 5
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Older that 18 years;
- •Suspect of peritoneal endometriosis, palpable nodule at physical examination;
- •Patient planned for MRI and laparoscopic treatment of the disease;
- •Pre menopausal;
- •Using contraception during the time of the study;
- •Willing and able to undergo all study procedures;
- •written informed consent.
Exclusion Criteria
- •Pregnancy / breast feeding;
- •Post menopausal status or under GnRH analogue treatment;
- •Patients presenting with a contraindication to MRI such as pacemaker, aneurysm clip, severe claustrophobia or ferromagnetic implants;
- •Impaired kidney function (estimated Glomerular Filtration Rate, eGFR \< 60\) or acute kidney injury;
- •History of severe allergic reaction or allergic reaction to MR contrast media;
- •Allergy (hypersensitivity) to any of the ingredients of Ablavar ®;
- •Being unable to give informed consent in person.
Outcomes
Primary Outcomes
Not specified
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